COVID-19 PandemicNCT06170307
Left Atrial Function of COVID-19-recovered Patients During the Surge of Omicron Variants
An observational study of COVID-19 Pandemic, run by Haiyan Wang at 1 site in China.
Trial summary
The goal of this observational study is to retrospectively analyze left atrial function in mild to moderate COVID-19-recovered patients. The main questions it aims to answer are: Whether left atrial function is involved in patients with mild to moderate COVID-19 after recovery. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Pandemic
- What is being tested?
- two-dimensional speckle tracking echocardiography
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2023to 20 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People who have recovered from mild to moderate COVID-19.
Who may be able to join
- 1. Patients having been diagnosed with SARS-CoV-2 Omicron variant infection based on real-time reverse-transcription polymerase chain reaction (RT-PCR) results; 2. Asymptomatic or mild to moderate COVID-19 patients. 3.COVID-19 patients who came to our hospital for echocardiography within 3 months after recovery.
Who cannot join
- Patients with decreased left ventricular ejection fraction (less than 50%), left ventricular segmental wall motion abnormalities, cardiomyopathy, severe valvular heart disease, arrhythmia, thyroid dysfunction, pulmonary hypertension, past or current pulmonary embolism, severe chronic obstructive pulmonary disease, malignancy/renal failure (less than 30) ml/min) or poor cardiogram image quality were excluded from the study.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, 250000
About this study
Official title: Assessment of Left Atrial Function of COVID-19-recovered Patients During the Surge of Omicron Variants by Two-dimensional Speckle Tracking Echocardiography
The goal of this observational study is to retrospectively analyze left atrial function in mild to moderate COVID-19-recovered patients. The main questions it aims to answer are:
- Whether left atrial function is involved in patients with mild to moderate COVID-19 after recovery.
- What are the factors that may be associated with persistent heart-related symptoms (including chest pain, chest tightness, palpitations, shortness of breath, or postural tachycardia) in patients with mild to moderate COVID-19 ?
Participants will undergo transthoracic echocardiography to obtain conventional ultrasound parameters, two-dimensional strain parameters will been obtained through software post-processing, and general clinical data and laboratory test results will been obtained.
Read the detailed description
The included patients who recovered from COVID-19 infection and healthy people underwent transthoracic echocardiography at the First Affiliated Hospital of Shandong First Medical University from December 20, 2022 to January 20, 2023. Routine data and two-dimensional strain parameters of transthoracic echocardiography of the study subjects were obtained:
- The echocardiographic examination was performed using a Epiq 7C ultrasound machine, and images were acquired with the patient in left lateral decubitus using a 3.5-5 MHz transducer at a depth of 16 cm. ECG was recorded, and 3 consecutive cardiac cycles of each view were recorded during quiet breathing at 50-80 frames/sec. All patients were subjected to conventional transthoracic echocardiography \& Speckle tracking echocardiography (STE). All measurements were taken following the American Society of Echocardiography (ASE) recommendations.
- Left atrial strain analysis was obtained using automated speckle tracking software. The regions of interest were generated automatically and Left atrial endocardial border was manually adjusted when required. Left atrial phases definition and Left atrial strain values were measured from the Left atrial longitudinal strain curve according to the European Association of Cardiovascular Imaging (EACVI)/American society of echocardiography (ASE) guidelines. Global LV systolic strain was evaluated, and the software automatically traced the contour of the endocardium at apical three, four and two-chamber views.
- At the same time, the general clinical data, demographic characteristics, electrocardiogram, chest CT results, troponin I (hsTnI) and brain natriol peptide levels on the day of echocardiographic examination were obtained through the hospital electronic medical record His system.
- Clinical follow-up was performed 12-18 months after the echocardiographic examination by phone and by electronic health record review. We recorded: 1) persistent cardiac symptoms, 2) interval presentation to the emergency department or hospitalization with cardiac symptoms, and 3) any major adverse cardiac event (myocardial infarction, stroke, revascularization, or death).
- Conditions
- COVID-19 Pandemic
- Being tested
- two-dimensional speckle tracking echocardiography
- Keywords
- COVID-19, Long COVID-19 syndrome, 2-dimensional speckle tracking imaging, echocardiography, Left atrial strain
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
two-dimensional speckle tracking echocardiographyOther
The structural and functional parameters of the left atrial were obtained by conventional echocardiography, and the left atrial strain parameters were obtained by two-dimensional speckle tracking echocardiography.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 group | Patients diagnosed with SARS-CoV-2 Omicron variant infection by SARS-CoV-2 RT-PCR test within 3 months who came to our hospital for echocardiography were included in the case group . Receives: Other: two-dimensional speckle tracking echocardiography | |
| Control group | Healthy participants were confirmed free of COVID-19 disease by reverse transcriptase-polymerase chain reaction (RT-PCR) testing and computed tomography (CT) imaging. Receives: Other: two-dimensional speckle tracking echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left atrial strain
Myocardial strain derived from speckle-tracking echocardiography has been shown to be more sensitive and accurate in detecting subclinical impairment of cardiac function than conventional echocardiography. LV diastolic dysfunction could be explained by Left atrial strain.
Measured: After recruiting, left atrial strain collected through software post-processing analysis will be assessed and reported up to 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start20 Nov 2023
- Primary completion20 Jul 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PandemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haiyan Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Haiyan Wang, Qianfoshan Hospital
- Investigators
- Haiyan Wang, Principal investigator, Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170307
- Sponsor's protocol ID
- YXLL-KY-2023(136)
- Status last verified
- Apr 2024
- First submitted
- 11 Dec 2023
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou B, Zhang Y, Han S, Zhang J, Song L, Wang H. Myocardial Dysfunction and Risk of Long COVID in Patients Recovered From Mild and Moderate COVID-19. Echocardiography. 2025 Mar;42(3):e70120. doi: 10.1111/echo.70120.
PubMed 40029146
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Left Atrial Function of COVID-19-recovered Patients During the Surge of Omicron Variants by Two-dimensional Speckle Tracking Echocardiography
- ClinicalTrials.gov ID
- NCT06170307
- Acronym / sponsor ID
- YXLL-KY-2023(136)
- Conditions
- COVID-19 Pandemic
- Keywords
- COVID-19, Long COVID-19 syndrome, 2-dimensional speckle tracking imaging, echocardiography, Left atrial strain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Haiyan WangUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 20 Jul 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to retrospectively analyze left atrial function in mild to moderate COVID-19-recovered patients. The main questions it aims to answer are:
- Whether left atrial function is involved in patients with mild to moderate COVID-19 after recovery.
- What are the factors that may be associated with persistent heart-related symptoms (including chest pain, chest tightness, palpitations, shortness of breath, or postural tachycardia) in patients with mild to moderate COVID-19 ?
Participants will undergo transthoracic echocardiography to obtain conventional ultrasound parameters, two-dimensional strain parameters will been obtained through software post-processing, and general clinical data and laboratory test results will been obtained.
Detailed description
The included patients who recovered from COVID-19 infection and healthy people underwent transthoracic echocardiography at the First Affiliated Hospital of Shandong First Medical University from December 20, 2022 to January 20, 2023. Routine data and two-dimensional strain parameters of transthoracic echocardiography of the study subjects were obtained:
- The echocardiographic examination was performed using a Epiq 7C ultrasound machine, and images were acquired with the patient in left lateral decubitus using a 3.5-5 MHz transducer at a depth of 16 cm. ECG was recorded, and 3 consecutive cardiac cycles of each view were recorded during quiet breathing at 50-80 frames/sec. All patients were subjected to conventional transthoracic echocardiography \& Speckle tracking echocardiography (STE). All measurements were taken following the American Society of Echocardiography (ASE) recommendations.
- Left atrial strain analysis was obtained using automated speckle tracking software. The regions of interest were generated automatically and Left atrial endocardial border was manually adjusted when required. Left atrial phases definition and Left atrial strain values were measured from the Left atrial longitudinal strain curve according to the European Association of Cardiovascular Imaging (EACVI)/American society of echocardiography (ASE) guidelines. Global LV systolic strain was evaluated, and the software automatically traced the contour of the endocardium at apical three, four and two-chamber views.
- At the same time, the general clinical data, demographic characteristics, electrocardiogram, chest CT results, troponin I (hsTnI) and brain natriol peptide levels on the day of echocardiographic examination were obtained through the hospital electronic medical record His system.
- Clinical follow-up was performed 12-18 months after the echocardiographic examination by phone and by electronic health record review. We recorded: 1) persistent cardiac symptoms, 2) interval presentation to the emergency department or hospitalization with cardiac symptoms, and 3) any major adverse cardiac event (myocardial infarction, stroke, revascularization, or death).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 group | – | Other: two-dimensional speckle tracking echocardiographyPatients diagnosed with SARS-CoV-2 Omicron variant infection by SARS-CoV-2 RT-PCR test within 3 months who came to our hospital for echocardiography were included in the case group . |
| Control group | – | Other: two-dimensional speckle tracking echocardiographyHealthy participants were confirmed free of COVID-19 disease by reverse transcriptase-polymerase chain reaction (RT-PCR) testing and computed tomography (CT) imaging. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People who have recovered from mild to moderate COVID-19.
Key inclusion criteria (1 listed)
- 1. Patients having been diagnosed with SARS-CoV-2 Omicron variant infection based on real-time reverse-transcription polymerase chain reaction (RT-PCR) results; 2. Asymptomatic or mild to moderate COVID-19 patients. 3.COVID-19 patients who came to our hospital for echocardiography within 3 months after recovery.
Key exclusion criteria (1 listed)
- Patients with decreased left ventricular ejection fraction (less than 50%), left ventricular segmental wall motion abnormalities, cardiomyopathy, severe valvular heart disease, arrhythmia, thyroid dysfunction, pulmonary hypertension, past or current pulmonary embolism, severe chronic obstructive pulmonary disease, malignancy/renal failure (less than 30) ml/min) or poor cardiogram image quality were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| two-dimensional speckle tracking echocardiographyThe structural and functional parameters of the left atrial were obtained by conventional echocardiography, and the left atrial strain parameters were obtained by two-dimensional speckle tracking echocardiography. | Other | COVID-19 group, Control group |
Primary outcome
Left atrial strain
Time frame: After recruiting, left atrial strain collected through software post-processing analysis will be assessed and reported up to 8 weeks.
Myocardial strain derived from speckle-tracking echocardiography has been shown to be more sensitive and accurate in detecting subclinical impairment of cardiac function than conventional echocardiography. LV diastolic dysfunction could be explained by Left atrial strain.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Derived from this study: PubMed 40029146Zhou B, Zhang Y, Han S, Zhang J, Song L, Wang H. Myocardial Dysfunction and Risk of Long COVID in Patients Recovered From Mild and Moderate COVID-19. Echocardiography. 2025 Mar;42(3):e70120. doi: 10.1111/echo.70120.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haiyan Wang principal investigator
Shandong First Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pandemic, run by Haiyan Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left atrial strain (time frame: After recruiting, left atrial strain collected through software post-processing analysis will be assessed and reported up to 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06170307, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.